Traditionally, pharmaceutical companies have been reluctant to adopt new technologies for fear of falling into regulatory non-compliance. The US Food and Drug Administration (FDA) has defined a framework -- referred to as Process Analytical Technology (PAT) -- that promotes voluntary implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Specifically, PAT is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and operations with the goal of ensuring final product quality.

TrakSYS™ is an effective Process Analytical Technology (PAT) enabler that safely introduces innovations that drive productivity without risking non-compliance. TrakSYS takes the guess out of the decision-making process by providing real-time information to the right people – regardless of where they are. By analyzing the impact of a multitude of variables across the value chain on product quality, yield, schedule compliance, goal attainment, and cost, TrakSYS empowers the stakeholders to make fact-based decisions that can deliver on the promise of quality by design. That’s why many of the largest global pharmaceutical and medical device companies have chosen TrakSYS to be an integral part of their operational excellence and continuous improvement initiatives.